MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number 10616

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).

Event Description

It was reported that the device was contaminated.A 4.00 x 8mm synergy ii drug eluting stent was selected for use.However, it was noted that the device was contaminated.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).B3 date of event: corrected.Date was estimated based on aware date as the actual date was not reported.The synergy ous mr 4.00 x 8mm stent delivery system (sds) was returned for analysis.No issues were noted with the hypotube shaft, outer/mid-shaft sections or the inner lumen of the device during visual/tactile inspection.Microscopic analysis showed no signs of stent damage and no signs of stent movement.The balloon cones were tightly wrapped and evenly folded and had not been subjected to positive pressure.The bumper tip showed no signs of distal tip damage.No device issues were identified during returned product analysis.

Event Description

It was reported that the device was contaminated.A 4.00 x 8mm synergy ii drug eluting stent was selected for use.However, it was noted that the device was contaminated.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17912352
• MDR Text Key: 325392319
• Report Number: 2124215-2023-54290
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: MO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10616
• Device Catalogue Number: 10616
• Device Lot Number: 0030508981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female